MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5552003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the x-stream laparoscopic tubing set suction cap fell off.The subject device was not returned for evaluation.The trumpet valve design on the x-stream irrigator allows for easy reverse configuration for left-handed use.The plug is assembled to the valve body during the manufacturing process with a torque screwdriver.If the plug was not inserted properly, minor leakage would occur.No leakage was reported.It is possible that the plug may have become unscrewed during use over time.However, without having the sample to evaluate, root cause cannot be determined.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This mdr represents the x-stream tubing set (device #2).An additional mdr was submitted to represent the x-stream tubing set (device #1).If/when additional information be provided a supplemental mdr will be submitted.
Event or Problem Description
The following was reported to bd by the fda via medwatch 3500a form # (b)(4): the bard/davol x-stream laparoscopic tubing: the cap (plug) of the suction irrigator fell off.Occurred twice.Additional information provided in follow up: it was reported that on 15-sep-2021, two x-stream laparoscopic tubing sets were used in the same case and the cap (plug) fell off both devices.The caps (plugs) were retrieved and there was no patient injury.

• Brand Name: X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12740625
• Report Number: 1213643-2021-20388
• Device Sequence Number: 17175482
• Product Code: GCJ
• UDI-Device Identifier: 00801741010101
• UDI-Public: (01)00801741010101
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 5552003
• Device Lot Number: JUFR1380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR